Quality Assurance Specialist
2 days ago
About the Role:
We are seeking a highly skilled Quality Assurance Specialist to join our team at ASK Consulting. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our manufacturing operations.
Key Responsibilities:
- Provide quality oversight of manufacturing operations to ensure compliance with cGMP regulations and company policies.
- Participate in shop floor and quality check walkthrough programs to identify and address quality issues.
- Review and approve batch records, material disposition, and product complaints.
- Develop and maintain department SOPs and review and approve CTDO SOPs.
- Perform real-time review and approval of executed batch records and chain of identity verification.
- Responsible for ERP material status changes of production/drug product.
- Maintain current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.
Requirements:
- Bachelor's degree in a scientific discipline or relevant college/university degree preferred.
- Equivalent combination of education and experience is acceptable.
- Strong knowledge of cGMP quality and compliance principles is required.
- Clinical and phase-appropriate experience preferred.
- Strong cross-functional collaboration experience is required.
About ASK Consulting:
ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states, ASK Consulting connects people with amazing opportunities.
ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.
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